Capecitabine/Oxaliplatin + Cemiplimab for Rectal Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Must not be taking: Chronic steroids, Monoclonal antibodies

Disqualifiers: Autoimmune disease, Heart disease, Infections, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new combination of drugs to determine their safety and effectiveness in treating rectal cancer that hasn't spread to distant parts of the body. The researchers combine drugs like capecitabine and oxaliplatin with cemiplimab (an immunotherapy drug) and other experimental treatments to improve outcomes before surgery. People with rectal cancer confined to nearby tissues who have not yet received treatment might be suitable for this study. The goal is to find a treatment that can shrink tumors and make surgery easier and more successful. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people, offering a chance to contribute to advancements in rectal cancer treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, you cannot use chronic systemic steroids or expect to need other cancer treatments while on the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the combination of capecitabine and oxaliplatin, known as CAPOX, is generally well-tolerated by patients. Studies have found that most patients can complete their treatment cycles with these drugs. For example, one study found that 66% of patients finished all their cycles, with high dose levels of 87% for oxaliplatin and 84% for capecitabine. This indicates that many patients can handle the treatment without major problems.

Cemiplimab has been used in other treatments and is being further studied for its safety when combined with other drugs. Fianlimab and REGN7075 are newer treatments currently undergoing testing. Since this study is in Phase 2, some safety information is available, but researchers continue to evaluate how well patients tolerate these combinations.

Participants in these trials receive close monitoring for any side effects, and the goal is to make treatments as safe as possible. While side effects can occur, researchers work to manage them and understand how these treatments can best help patients with rectal cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the treatments being tested for rectal cancer because they incorporate innovative immunotherapy agents. Unlike standard chemotherapy treatments like 5-FU and leucovorin, these new options combine traditional drugs like Oxaliplatin and Capecitabine with immune checkpoint inhibitors such as Cemiplimab and Fianlimab, and the investigational agent REGN7075. Cemiplimab and Fianlimab enhance the body's immune response to cancer cells, potentially offering a more targeted approach. REGN7075 is an exciting addition because it works as a bispecific antibody, which could provide a more potent attack on cancer cells. These combinations aim to improve the effectiveness of existing treatments by harnessing the body's immune system to fight cancer more efficiently.

What evidence suggests that this trial's treatments could be effective for rectal cancer?

Studies have shown that a combination of capecitabine and oxaliplatin (CAPOX) effectively treats certain cancers. After surgery, this combination has a 74% chance of preventing cancer recurrence for at least three years. In this trial, participants in Arm A will receive CAPOX with cemiplimab, an immunotherapy that helps the immune system fight cancer cells. Arm B will test the addition of fianlimab to the CAPOX and cemiplimab regimen, while Arm C will evaluate the addition of REGN7075. These combinations aim to enhance treatment effectiveness against rectal cancer. Early findings suggest these combinations could be more potent in fighting cancer, but further research is needed to confirm this. ^{2 3 5 6 7}

Who Is on the Research Team?

Eric Christenson, MD

Principal Investigator

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for patients with locally advanced rectal cancer that's microsatellite stable (MSS). They should have specific stages of the disease, like T2 node-positive or T3 with or without node involvement. Detailed eligibility criteria are not provided.

Inclusion Criteria

I am fully active or can carry out light work.

My rectal cancer is not linked to certain genetic instabilities.

My cancer is at a specific stage and involves certain lymph nodes.

Exclusion Criteria

Received an investigational agent or used an investigational device within 28 days of the first dose of study drug

History of severe hypersensitivity reaction to any monoclonal antibody

Active autoimmune disease

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive neoadjuvant treatment with capecitabine/oxaliplatin (CAPOX) combined with cemiplimab, cemiplimab/fianlimab, or cemiplimab/REGN7075

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of pathologic complete response (pCR) and event-free survival (EFS)

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Capecitabine
• Cemiplimab
• Fianlimab
• Oxaliplatin
• REGN7075

Trial Overview

The study tests combining cemiplimab alone or with fianlimab/REGN7075 and CAPOX chemotherapy in treating rectal cancer before surgery. It aims to assess safety and how well these combinations work against the cancer.

How Is the Trial Designed?

Group I: Arm C (Oxaliplatin, Capecitabine, Cemiplimab, REGN7075) Experimental Treatment 4 Interventions

Group II: Arm B (Oxaliplatin, Capecitabine, Cemiplimab, Fianlimab) Experimental Treatment 4 Interventions

Group III: Arm A (Oxaliplatin, Capecitabine, Cemiplimab) Experimental Treatment 3 Interventions

Who Is Running the Clinical Trial?

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead Sponsor

Trials

578

Recruited

33,600+

Regeneron Pharmaceuticals

Industry Sponsor

Trials

690

Recruited

948,000+

Founded

1988

Headquarters

Tarrytown, USA

Known For

Precision medicine

Top Products

Dupixent, EYLEA, Libtayo, Praluent

Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6946745/

Phase II study of capecitabine plus oxaliplatin (CapOX) as ...

The completion rate of all eight cycles of CapOX therapy was 66%. Relative dose intensities were 87% for oxaliplatin and 84% for capecitabine.

2.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2023.41.4_suppl.TPS276

Ensemble study: A multicenter, randomized, phase III trial ...

Ensemble study: A multicenter, randomized, phase III trial to test the superiority of consolidation irinotecan, capecitabine and oxaliplatin ...

3.

frontiersin.org

frontiersin.org/journals/medicine/articles/10.3389/fmed.2025.1582683/full

Oxaliplatin combined with capecitabine therapy and ...

(42) suggested that 3-year disease-free survival was 74% in the oxaliplatin and capecitabine chemotherapy after surgery, and was considered a ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/29158365/

Phase II Trial Using a Combination of Oxaliplatin ...

A trial combining chemoradiation and COX-2 inhibition was conducted to evaluate the pCR rate, surgical outcomes, survival, and treatment toxicity.

5.

ecancer.org

ecancer.org/en/news/12832-study-shows-new-second-line-therapy-for-metastatic-colorectal-cancer-is-effective-and-safe

Study shows new second line therapy for metastatic ...

Capecitabine combined with oxaliplatin (XELOX) has demonstrated comparable efficacy and safety to FOLFOX for the management of metastatic and ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07281768

Capecitabine/Oxaliplatin Chemotherapy and Cemiplimab ...

The purpose of this study is to evaluate the safety and clinical activity of combining cemiplimab, cemiplimab/fianlimab, or cemiplimab/REGN7075 ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6114242/

Prospective clinical study of capecitabine plus oxaliplatin ...

The capecitabine combined oxaliplatin therapy (CAPE-OC-CRT) did not increase the 3-year overall survival (OS) for patients after radical resection of rectal ...